UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of group exercise on cognitive function and amount of conversation randomized control trial in older people with social frailty
Title of the study (Brief title)	Effects of group exercise on cognitive functions and amount of conversation: RCT in older people with social frailty
Region	Japan

Condition
Condition	Social frailty
Classification by specialty	Geriatrics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of group exercise on amount of conversation and cognitive functions
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	1)Cognitive function Word memory 2)Communication in daily living
Key secondary outcomes	1)Physical activity 2)Cognitive function Executive function Attention Processing speed 3)Brain volume 4)Depressive symptoms 5)Physical function Grip strength Gait speed

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group: Perform group exercise for 90 min /a week for 44 times
Interventions/Control_2	Control group: self-conducted activity using self-monitoring note
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Satisfy the criteria of social frailty 2) Being able to exercise 3) 75 years or older 4) Being agreed with participation in the study
Key exclusion criteria	1) Have serious or unstable illness 2) Have disability 3) Have difficulty in exercise
Target sample size	104

Research contact person
Name of lead principal investigator	Hiroyuki Shimada
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Preventive Gerontology
Address	7-430, Morioka-cho, Obu city, Aichi, 474-8511, Japan
TEL	0562-44-5651
Email	shimada@ncgg.go.jp

Public contact
Name of contact person	Kota Tsutsumimoto
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Preventive Gerontology
Address	7-430, Morioka-cho, Obu city, Aichi, 474-8511, Japan
TEL	0562-44-5651
Homepage URL
Email	k-tsutsu@ncgg.go.jp

Sponsor
Institute	Department of Preventive Gerontology, National Center for Geriatrics and Gerontology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japanese

Other related organizations
Co-sponsor	Obu city
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 22 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 21 Day
Last modified on	2016 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026822